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| Name | Class |
|---|---|
| Azienda Ospedaliera Universitaria Renato Dulbecco | OTHER |
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This clinical investigation aims to compare the mental health status of caregivers of psychiatric patients before and after virtual reality-based mindfulness. The study's primary objectives are to:
Those who voluntarily sign up for the study will participate in four sessions, one each week, on the same day and at the same time. Prior to and following the mindfulness intervention, self-administered psychometric assessment batteries will be completed.
While the control group will use ears to complete the mindfulness session using immersive audio, the experimental group will get a virtual reality-mediated mindfulness intervention. BECOME is the company that provides the audio and video content.
In a sample of caregivers who visit the Department of Psychiatry at the "Renato Dulbecco" University Hospital in Catanzaro, the effects of the combined VR plus immersive audio treatment will be compared with the effects of immersive audio stimulation alone using a randomized controlled trial (RCT) design.
The main goal is to evaluate how much the experimental group's caregivers' mental health has improved both before and after therapy. The following self-report measures will be used for assessment: The World Health Organization Well-Being Index (WHO-5), the Zarit Burden Interview (ZBI), the Perceived Stress Scale (PSS-10), the Italian Mental Health Continuum-Short Form (MHC-SF), the Scale of Positive and Negative Experiences (SPANE), the Beck Depression Inventory-II (BDI-II), the State-Trait Anxiety Inventory (STAI), and the Pittsburgh Sleep Quality Index (PSQI).
Assessing variations in treatment effectiveness between the experimental and control groups is the secondary goal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness and virtual reality | Experimental | To examine changes in psychological factors, the same psychometric tests will be administered to both groups before and after each intervention. This group participate in a 10-minute virtual reality-mediated mindfulness protocol. |
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| Mindfulness and audio | Experimental | To examine changes in psychological factors, the same psychometric tests will be administered to both groups before and after each intervention. This group participate in a 10-minute immersive audio-mediated mindfulness protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR (VR-Control) | Device | Using the Meta Quest Pro headset, participants will participate in four virtual reality mindfulness exercises designed to improve relaxation and body awareness. Become's proprietary system (https://discoverbecome.com/) will be used for the sessions. The following is how the immersive "Augmented Wellbeing" sessions will be organized:
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| Measure | Description | Time Frame |
|---|---|---|
| State-Trait Anxiety Inventory (STAI) | From enrollment to the end of treatment at 4 weeks | |
| Beck Depression Inventory (BDI-II) | From enrollment to the end of treatment at 4 weeks | |
| Italian Mental Health Continuum - Short Form (MHC-SF) | From enrollment to the end of treatment at 4 weeks | |
| Perceived Stress Scale (PSS-10) | From enrollment to the end of treatment at 4 weeks | |
| WHO-5 | From enrollment to the end of treatment at 4 weeks | |
| Mindful Attention Awareness Scale (MAAS) | From enrollment to the end of treatment at 4 weeks | |
| Zarit Burden Interview (ZBI) | From enrollment to the end of treatment at 4 weeks | |
| Scale of Positive and Negative Experiences (SPANE) | From enrollment to the end of treatment at 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU "Renato Dulbecco" | Catanzaro | Catanzaro | 88100 | Italy |
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Randomized control trial
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| Audio immersivo | Device | In order to improve body awareness and relaxation, participants will participate in four audio-only mindfulness sessions (immersive mindfulness audio). The same firm, BECOME, provides the audio track, which is the same as the one used in the VR immersive sessions. The number and length of sessions completed by participants will be identical to those of the experimental group, and the sessions will follow the same format:
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